Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients With Cardiovascular Disease Who Are Non-Adherent With Positive Airway Pressure: A Randomized Placebo-Controlled Pilot Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04205136
• Other study ID #: HUM00147375
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2022
• Est. completion date: April 2023

Study information

• Verified date: April 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether Spironolactone can improve the severity of obstructive sleep apnea and improve cardiovascular biomarkers in people who are not regularly using their Positive Airway Pressure (PAP) therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) greater than or equal to 30
• Diagnosis of moderate to severe OSA via diagnostic polysomnography (AHI=15) or home sleep apnea test (respiratory event index (REI)=15).
• Diagnosis of cardiovascular disease
• Meet criteria for hypertension (minimum systolic blood pressure = 140 but <180)
• Prescribed PAP therapy but non-adherent (failure to use PAP for at least 4 hours per night on minimum 5/7 nights per week on average over a one-month period)

Exclusion Criteria:

• Diagnosis of congestive heart failure; resistant hypertension; hepatic disease; Addison's disease; cancer; or recent (past 3 months) myocardial infarction, or stroke
• Diagnosis of central sleep apnea
• Patients who are not using PAP at all (untreated) or using another form of treatment for OSA
• Currently taking, recent trial (past month), or allergy for spironolactone
• Severe respiratory disease (e.g., diagnosis of chronic obstructive pulmonary disease, uncontrolled asthma)
• History of leukopenia and/or thrombocytopenia
• Current use of another potassium sparing diuretic (e.g., amiloride or eplerenone)
• Current use of lithium, barbiturates, narcotics, muscle relaxants, pressor amines, or cholestyramine
• Patients who plan to have surgery during the time period of the study

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Spironolactone
If tolerated and serum potassium <5.0 meq/L, the dose will be increased to 50 mg (2 pills) after 4 weeks. If serum potassium is >5.0 but less than 5.5 or creatinine >4.0 mg/dL, the dose will be adjusted to 25 mg every other day; if potassium levels =5.5 in a non-hemolyzed blood sample, the medication will be discontinued.
• Placebo
Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in apnea-hypopnea index (AHI)	AHI is obtained from polysomnography studies	Day 0, Day 84
Secondary	Change in minimum oxygen saturation (SaO2)	Oxygen saturation is obtained from polysomnography studies	Day 0, Day 84
Secondary	Change in Inflammatory biomarker	Biomarkers of interest will be obtained via blood draws. Markers of interest: Interleukin 6 protein (IL-6), Tumor necrosis factor alpha (TNF a), High Sensitivity C-Reactive Protein, Brain Natriuretic Peptide (BNP), and procollagen 1 and 3.	Day 0, Day 84
Secondary	Change in Diurnal blood pressure	Measured using SPRINT methods; Seated blood pressure is measured after a rest period using an automated device or manual devices if necessary. The preferred method is the automated device. Both systolic and diastolic blood pressure will be measured.	Day 0, Day 84